Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050514
Company: HARROW EYE

Products on NDA 050514

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NATACYN	NATAMYCIN	5%	SUSPENSION;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050514

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/30/1978	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
07/18/2008	SUPPL-9	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050514s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050514s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/050514Orig1s009Lbl.pdf
10/19/2000	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/02/1997	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
11/01/1995	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
02/10/1992	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/30/1992	SUPPL-4	Labeling		Label is not available on this site.
03/08/1991	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 050514

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2008	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050514s009lbl.pdf